Cinryze Side Effects Center

Last updated on RxList: 11/21/2022
Cinryze Side Effects Center

What Is Cinryze?

Cinryze (c1 esterase inhibitor [human]) Freeze Dried Powder is a man-made form of a protein that occurs naturally in the bloodstream and helps control inflammation in the body and is used in people with hereditary angioedema. The Berinert brand of this medication is used to treat attacks of angioedema. The Cinryze brand is used to prevent attacks of angioedema.

What Are Side Effects of Cinryze?

Serious blood clots may occur with Cinryze. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:

  • pain and/or swelling of an arm or leg with warmth over the affected area
  • discoloration of an arm or leg
  • unexplained shortness of breath
  • chest pain or discomfort that worsens on deep breathing
  • unexplained rapid heart rate
  • numbness or weakness on one side of the body

Common side effects of Cinryze include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Cinryze

A dose of 1,000 Units Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients.

What Drugs, Substances, or Supplements Interact with Cinryze?

Cinryze may interact with other drugs. Tell your doctor all medications and supplements you use.

Cinryze During Pregnancy and Breastfeeding

During pregnancy, Cinryze should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Cinryze (c1 esterase inhibitor [human]) Freeze Dried Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Allergies can best be described as: See Answer
Cinryze Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • sudden numbness or weakness on one side of the body;
  • pain, swelling, warmth, or redness in an arm or leg;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain while taking deep breaths; or
  • fast heart rate.

Common side effects may include:

  • unusual or unpleasant taste in your mouth;
  • headache, dizziness;
  • nausea, vomiting;
  • pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;
  • stuffy nose, sore throat;
  • rash; or
  • fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Could I Be Allergic? Discover Your Allergy Triggers See Slideshow
Cinryze Professional Information

SIDE EFFECTS

The most common adverse reactions (≥5%) observed were headache, nausea, rash, vomiting, and fever.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Twenty-four subjects age 9 to 73 years old were evaluated in the randomized, placebo-controlled, crossover, routine prophylaxis trial. There were no serious adverse reactions in the randomized, placebo-controlled, crossover, routine prophylaxis trial.

Adverse reactions in the randomized, placebo-controlled, crossover, routine prophylaxis trial (n=24) that occurred in at least two subjects (≥8%) receiving CINRYZE are given in Table 2:

Table 2 Adverse Reactions in the Randomized, Placebo-Controlled, Crossover, Routine Prophylaxis Trial.

Adverse Reaction Number of Adverse Reactions Number of Subjects (N = 24)
Rash 8 5
Headache 4 4
Pruritus 2 2
Vomiting 2 2

In an open-label follow-on trial, 146 subjects age 3 to 82 years old received a median of 243.5 days of CINRYZE (maximum = 959 days). The most common adverse reaction observed was headache. No subjects were discontinued due to an adverse reaction.

Adverse reactions in the open-label follow-on trial (n=146) that occurred in at least three subjects (≥2%) receiving CINRYZE, are given in Table 3:

Table 3 Adverse Reactions in the Open-Label Follow-On Trial.

Adverse Reaction Number (%) of Subjects (N=146) with Adverse Reaction Number (%) of Infusion Days (N=11,435) with Adverse Reaction
Headache 28 (19) 62 (0.5)
Nausea 26 (18) 29 (0.3)
Rash 15 (10) 30 (0.3)
Vomiting 15 (10) 17 (0.1)
Pyrexia (fever) 7 (5) 7 (<0.1)
Catheter Site Pain 4 (3) 5 (<0.1)
Dizziness 3 (2) 4 (<0.1)
Erythema 3 (2) 3 (<0.1)
Pruritus 3 (2) 4 (<0.1)

Serious adverse reactions included cerebrovascular accident (see WARNINGS AND PRECAUTIONS).

Twelve pediatric subjects age 7 to 11 years old were evaluated in a randomized, dose-ranging, crossover routine prophylaxis trial (500 U and 1000 U). No new adverse reactions (compared to the placebo-controlled routine prophylaxis trial or the open label follow-on trial) were identified. The adverse reactions among the pediatric subjects were headache, nausea, pyrexia (fever), and infusion site erythema. None of these adverse reactions were severe, and none led to discontinuation of CINRYZE. The safety profile with 500 U or 1000 U of CINRYZE treatment was comparable. Overall, the safety and tolerability of CINRYZE are similar in pediatric, adolescent, and adult subjects.

More than 14,000 doses of CINRYZE have been administered to over 260 different subjects in all completed, controlled and open-label clinical studies. All subjects who were evaluated were found negative for seroconversion to parvovirus B19, Hepatitis B, Hepatitis C and HIV. (see WARNINGS AND PRECAUTIONS)

A post-approval open-label study assessed escalating doses of CINRYZE (1,500 U, 2,000 U, 2,500 U every 3 or 4 days) as prophylactic therapy in 20 subjects who had an inadequate response (> 1.0 HAE attack/month, regardless of severity) to 1,000 U every 3 or 4 days. The safety profile of doses up to 2,500 U was consistent with previous clinical trial experience at lower doses.

Immunogenicity

Because CINRYZE is a therapeutic protein, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of anti-C1 esterase inhibitor antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibody development across products cannot be made.

Postmarketing Experience

Because post marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Postmarketing adverse reactions included local infusion site reactions (including inflammation or hematoma at the infusion site) and hypersensitivity.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder)

© Cinryze Patient Information is supplied by Cerner Multum, Inc. and Cinryze Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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